Consultation: Strengthening monitoring of medicines in Australia
Enhanced medicines vigilance
This consultation closes on 1 May 2017.
Invitation to comment
The TGA is seeking comments from interested parties on the proposed enhancements to the safety monitoring of medicines in Australia.
- Consultation: Strengthening monitoring of medicines in Australia - Enhanced medicines vigilance (pdf,255kb)
- Consultation: Strengthening monitoring of medicines in Australia - Enhanced medicines vigilance (Microsoft Word,192kb)
Documents released for consultation on Monday, 20 March 2017.
Interested parties should respond by close of business Monday, 1 May 2017.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
The TGA is proposing to implement changes that will strengthen safety monitoring for medicines available in Australia. The changes will apply to medicines only and will be implemented progressively from late 2017 onward.
The attached consultation document describes the changes proposed and poses questions where feedback is being sought.
The MMDR Review made one recommendation intended to cover a wide range of improvements to the safety monitoring of medicines and medical devices in Australia. The scope of these changes is outlined in Recommendation 27 of the document Review of Medicines and Medical Devices Regulation - Recommendations.
The recommendation is intended to improve communication and collaboration, use of data and the collection of adverse events.
Content of submissions
Submissions may address any, or all, of the proposals included in the Strengthening monitoring of medicines in Australia consultation document.
How to respond
Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.
Alternatively, hardcopy submissions with a printed coversheet may be mailed to:
Reforms and Operations Section
Pharmacovigilance and Special Access Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (please complete the online form).
- Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
Any questions relating to submissions should be directed to the Reforms and Operations Section of the Pharmacovigilance and Special Access Branch by email to ReformsandOperations@health.gov.au.